MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for thrombus and tissue damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced across the septum and a small clot or piece of tissue was noted on the dilator.The dilator was removed and the clot/tissue was no longer seen.It was unknown if the clot/tissue was removed with the dilator or if it remained in the patient anatomy.The activated clotting time was noted to be above 250, at therapeutic level.No additional intervention was performed to treat the clot/tissue.The procedure continued with the same sgc and one clip was implanted.The mr was reduced from grade 4 to grade 1-2.There was no adverse patient sequelae or clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device is not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Thrombosis/thrombus is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Based on the information reviewed, a definitive cause for the reported patient effect could not be determined in this case.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11773920
• MDR Text Key: 263887136
• Report Number: 2024168-2021-03792
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10106U125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Weight: 69